Hemolysis reagent composition for hemoglobin a1c quantitative analysis using enzymatic method

Abstract

Disclosed is a hemolysis reagent composition for the quantitative analysis of glycated hemoglobin (HbAlc) via an enzymatic method. The hemolysis reagent compositions of the present invention containing a zwitterionic surfactant and a nitrous compound considerably accelerate hemolysis rate due to the presence of the zwitterionic surfactant, and also induce the N-terminal β-chain of hemoglobin released by hemolysis to be exposed to the outside of the hemoglobin molecule and assists the participation of a greater number of molecules in the reaction, thereby improving reaction sensitivity and reaction rate of the glycated hemoglobin, and the nitrous compound makes the protein structure of the hemoglobin flexibly modified so that the amino acid sequence of the N-terminal β-chain of hemoglobin can be readily cut off, thereby significantly reducing the entire time required for the measurement and improving the accuracy of the measurement.

Description

TECHNICAL FIELD[0001]The present disclosure relates to a novel hemolysis reagent composition for quantitative analysis of glycated hemoglobin using an enzymatic method.BACKGROUND ART[0002]Recently, there has been a growing concern on the necessity of a periodic checkup on the blood glucose level for the diagnosis and prevention of diabetes. The blood glucose level can be easily measured using a portable blood glucose monitoring device, in particular, using a strip type biosensor by each individual.[0003]However, it is inconvenient to use because the results of blood glucose measurements varies depending on whether a patient has taken a meal or not, and the measured value may vary depending on the patient's physical conditions on the examination day, e.g., stress, drinking, fatigue, etc.[0004]In contrast, when a diabetic patient is measured and managed using glycated hemoglobin (HbA1c), the result is not affected by factors such as physical conditions of the patient or whether the pa...

AI Technical Summary

Benefits of technology

The present invention provides a hemolysis reagent composition that contains a zwitterionic surfactant and a nitrous compound. This composition accelerates the rate of hemolysis and improves the sensitivity and reaction rate of measuring HbA1c. The nitrous compound also makes the protein structure of hemoglobin flexible, allowing the N-terminal β-chain of hemoglobin to be readily cut off, which reduces the time required for the measurement and improves accuracy.

Problems solved by technology

However, it is inconvenient to use because the results of blood glucose measurements varies depending on whether a patient has taken a meal or not, and the measured value may vary depending on the patient's physical conditions on the examination day, e.g., stress, drinking, fatigue, etc.

However, the standard method described above has a disadvantage that it can be only performed in a well-facilitated major clinical laboratory or a hospital's central laboratory by a trained clinical professional and the operation and maintenance is relatively costly, esp. when fewer tests are ordered.

However, the amount of the supplies is very limited due to the lack of companies producing the same, and also the apparatus is very complicated requiring a reaction-separation step.

However, its drawbacks include using high cost antibodies, and having a difficulty in manufacturing sensors with uniform quality due to non-uniformity in porous pads.

Therefore the measurement of glycated proteins is compromised and performance with regard to reproducibility is undermined.

The enzymatic method using various enzymes as described above has an advantage that it can provide a more accurate result due to the enzyme's characteristic of selectivity compared to other methods, but it has a disadvantage that it requires a long reaction time and its reaction sensitivity is low due to sophisticated reaction conditions.

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